Status:

RECRUITING

AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients With Baseline Brain Metastases

Lead Sponsor:

Fudan University

Conditions:

NSCLC (Advanced Non-small Cell Lung Cancer)

Brain Metastasases

Eligibility:

All Genders

18+ years

Brief Summary

The goal of this observational study is to extract the imaging features of brain lesions and primary lung lesions in NSCLC patients with brain metastases by deep learning, as well as common clinicopat...

Eligibility Criteria

Inclusion

  • Pathologically confirmed non-small cell lung cancer;
  • clinical stage IV (AJCC, 8th edition, 2017);
  • EGFR sensitive mutations: EGFR L858R, EGFR exon 19 deletion;
  • age≥18 years old;
  • KPS score≥70;
  • brain metastases at diagnosis;
  • complete systemic imaging (including brain MRI) before third-generation EGFR-TKI treatment;
  • received standard third-generation EGFR-TKI therapy (monotherapy or combined with brain radiotherapy);
  • willing to cooperate with the follow-up after third-generation EGFR-TKI treatment;
  • informed consent of the patient.

Exclusion

  • Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
  • Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI;
  • EGFR sensitive mutations were negative or EGFR mutation status was not detected.
  • Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.

Key Trial Info

Start Date :

September 30 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 1 2025

Estimated Enrollment :

800 Patients enrolled

Trial Details

Trial ID

NCT06604689

Start Date

September 30 2024

End Date

October 1 2025

Last Update

November 12 2024

Active Locations (1)

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Shanghai Cancer center

Shanghai, Shanghai Municipality, China, 200050